Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded Clinical Trials using its collaborative Contract Research Organisation (CRO), extensive Clinical Research Facility (CRF) Network, and leading Therapy Development Program. Clerkenwell Heath specialises in supporting the Mental Health and CNS (Central Nervous System) space with a focus on psychedelic drug development.

The CRF Manager is responsible for the day-to-day management of the Clinical Research Facility and the management of the Nursing and Operational Team within that facility.

Main Duties and Accountabilities

Strategy

• Work with the SLT on all Business Development tasks to support the CRF
• To provide professional leadership to all operational staff at all levels throughout the CRF
• Oversee and/or assist in the recruitment and on-going management (where appropriate), development and support of CRF staff team.
• Maintain an awareness of best practice with regard to managing and developing staff using appropriate team building and change management skills to ensure the cohesiveness, effectiveness and continuity of the function.
• Contribute to the development of training programmes as required.

Finance and General Management

• Contribute to the management, monitoring, control, and reporting of budgets, working closely with the Commercial Director, Functional Heads, Founders and appropriate external organisations.
• Advise on financial and contractual management for projects and awards in conjunction with the SLT.
• Oversee the vendor selection process, liaising with the Quality Assurance team to follow internal risk assessment and due diligence processes. Oversee vendor management, escalating performance and delivery risks to the Director of Operations as required.

CRF Overview

• Undertake nursing activities relating to clinical trials from the start-up of a trial to the close out, working to ICH/GCP guidelines.
• Review research protocols, identify and coordinate training and education requirements for clinical reports.
• Ensure the commercial success of the site by contributing to the recruitment and retention of participants into trials.
• Screening and randomisation of potential study participants.
• Conducting informed consent discussions and taking informed consent.
• Ensuring the completion of study procedures such as phlebotomy, vital signs and ECG and reviewing medical histories.
• Scheduling trial visits and tracking enrolled trial participants.
• Completing and organising regulatory documents.
• Communicating with the Sponsor, regulators, and third party vendors.
• Performing all coordinator-mediated tasks, per individual protocols,
• Drug accountability and reconciliation.
• Processing and packaging specimens, per guidelines.

Clinical Trial Management (CTIMPs and Non-CTIMPs)

• Obtain informed consent from participants for CTIMP and non-CTIMP studies as delegated by Principal Investigator (PI) and within parameters of the protocol.
• Support participants considering participation with the decision-making process, ensuring that their information needs are met sensitively and that they have a full understanding of the study, its requirements and their rights as participants.
• Ensure all adverse events are reported in line with the protocol adverse events reporting policy.
• Facilitate and maintain (written and verbal) communication between the PI, research and clinical teams in ensuring that the study protocol is correctly implemented, and research governance standards are met and maintained.
• Ensuring that all equipment used in the trial is appropriately calibrated and that supporting documentation is retained.
• Ensure the appropriate execution of all visits and clinical procedures such as monitoring vital signs, body measurements, height and weight, ECGs, venepuncture, cannulation, and drug administration in accordance with the procedures and schedule of the study protocol.
• Ensure all laboratory work is completed as per study protocols, including processing, packaging, storing and transportation of samples.
• Provide ongoing support to patients and volunteers with regards to their trial participation.
• Ensure that all clinical trial databases and logs are maintained including updating patient recruitment data on our systems, on a weekly basis.
• Ensure protocol amendments are incorporated into research practice in a timely manner.
• Work within the scope of research guidelines, ethical principles and protocols, whilst adhering to organisational policies and procedures.
• Ensure the security and confidentiality of patient information at all times, in accordance with all relevant laws and regulations.

General Clinical Duties

• Support colleagues in assessing, planning and implementing high quality care, and evaluating care options for patients in the clinical area, in line with the Clerkenwell values and objectives.
• Work with the CRF team to ensure the safe custody, maintenance and administration of medication, in accordance with established Clerkenwell policies.
• Promote and maintain a safe therapeutic environment for patients, their families and staff, according to national and local Infection Control guidelines, Health & Safety legislation and Clerkenwell policies and objectives.
• Provide sound evidence-based advice, as required, to staff and patients.
• Maintain a good understanding and implementation of clinical escalation procedures as required.
• Understand the Clerkenwell clinical governance framework and participate in the promotion and safeguarding of high standards of care, through effective risk management & governance, and adherence to the Clerkenwell values.
• Ensure that the team promote and adhere to the Clerkenwell safeguarding polices.
• Undertake effective multi-professional work with colleagues to deliver care.
• Monitor quality of standards of care in line with ICH-CGP and CQC requirements and Clerkenwell and Divisional objectives.
• Facilitate a high-quality patient experience.
• Maintain a safe working environment ensuring equipment is safe and used in line with Clerkenwell policy and values.
• Promote and maintain patient safety at all times.
• Have an awareness of current professional and clinical developments within their area of practice and promote this to others.

Clinical Trial Set Up (CTIMPs and Non-CTIMPs)

• Liaise with the Sales, Science and Clinical Operations functional leads to identify trials in the pipeline.
• Contribute to the assessment of trial protocols, safety, regulatory and logistical issues in the running of the trial.
• Contribute to expressions of interest (EOIs) and trial feasibility meetings.
• Liaise with Sponsors, CROs or other trial personnel to ensure all trials have the necessary regulatory and local site approval confirmation prior to commencement.
• Ensure compilation and maintenance of all site files in accordance with ICH-GCP.
• Assist with the set-up of studies and attend Site Initiation Visits.

Study Close Out

• Ensure all data clarification issues are resolved quickly.
• Assist with the archiving of study related documentation in line with the Trial Agreement and ICH-GCP.

Resource Management

• Plan resource and capacity for CRF operations as new trials are assigned.
• Ensure the CRF is adequately staffed.
• Support senior colleagues in ensuring research delivery within capacity.
• Shared responsibility for the safe use, maintenance and storage of computers, photocopiers and other office equipment.
• Contribute to effective stock control/maintenance.
• Manage the physical resources required to undertake research activity including monitoring that those resources are fit for purpose (for example that they are within manufacturer’s date and/or calibrated) and that they are used appropriately.

Administrative Duties

• Support the research team, sponsors and CRO in the maintenance of investigator site files and working files.
• Complete Case Report Forms (CRFs) including eCRFs with a high degree of accuracy.
• Set up and maintain study trackers.
• Implement study amendments.
• Locate and track medical records.
• Manage and participate in monitoring visits.
• Oversee filing of research material such as laboratory and imaging reporting.
• Complete annual monitoring study reports.

Attainments / Qualifications

Essential:

• Undergraduate degree in a relevant discipline.
• Formal training in Good Clinical Practice (GCP).
• Degree/postgraduate qualification/professional qualification or equivalent plus extensive relevant experience.

Skills and Understanding

Essential:

• Extensive knowledge and in-depth understanding of clinical trials management, including Clinical Trials of Investigational Medical Products (CTIMPs), and a track-record of successful delivery of multi-centre interventional research studies.
• Strong skills in team leadership and motivating staff.
• In-depth knowledge of the principles of GCP, the EU Clinical Trials Directive and related UK Clinical Trials regulations, and the UK Policy Framework for Health and Social Care Research.

Prior Experience

Essential:

• Significant experience in the management of clinical trials, including Clinical Trials of Investigational Products (CTIMPs) at project management level, and of working according to Good Clinical Practice (GCP) the international ethical, scientific and practical standards to which all clinical research is conducted.
• Significant experience of writing trial documentation, including protocols, oversight committee reports, funder reports and SOPs (Standard Operating Procedures), as well as research papers.
• Experience and proven ability of line managing and developing staff.
• Experience of chairing multi-disciplinary meetings.
• Experience of making applications to regulatory bodies (MHRA (Medicines and Healthcare Products Regulatory Agency)) and to research ethical committees via IRAS.
• Experience of leading the writing of research papers (e.g., trial protocol papers).